Linguaflex, Inc.
The LinguaFlex™ Tongue Retractor (LTR) is an investigational medical device that is inserted into the tongue to lessen its backward movement during sleep. This helps to keep the airway open during sleep so that the tongue doesn't block the airway causing obstructive apnea or narrow it enough to cause snoring. This study will monitor the effectiveness of the LTR device in the reduction of Obstructive Sleep Apnea and snoring over the course of a one-year treatment period.
The study design is a multi-site, prospective, open-label, non-randomized, single-arm clinical study to test the efficacy of the LinguaFlex Tongue Retractor for the treatment of moderate to severe Obstructive Sleep Apnea (OSA) (AHI ≥15 at baseline) in adult subjects in twelve (12) months of continuous use. The study will include three (3) investigational sites that will implant a maximum of eighty (80) subjects with the LTR. No single site is to perform more than 35 implants. After informed consent is obtained, eligible subjects (adults who have moderate to severe OSA) will be screened for stu…
Inclusion Criteria: * Subjects able to read, understand and sign consent * Subjects 18 years or older with: 1. Moderate to severe OSA (AHI of ≥ 15 to ≤ 50 as determined by a Diagnostic PSG recording within 2 months of inclusion) 2. Subject agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in the clinical trial: * \< 18 years of age * AHI \< 15(mild OSA) * AHI \> 50 * Subjects with \> 20% of AHI score accounted for from cent…
The LinguaFlex Tongue Retractor (LTR) is a small, flexible, implanted tongue retaining device that lessens the backward movement of the tongue during sleep. The LTR's flexible shaft and a nubbed tether passes through the center of the tongue beneath the tongue blade (frenulum area) and connects to a disc (head) that rests on the external surface of the tongue base mucosa. Underneath the tongue, on the external surface of the frenulum, a small anchor secures the shaft that can be adjusted to tension the LTR to maximize therapeutic effect and maintain comfort.
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